Home / Device Classification / GXH

GXH — Device, Surgical, Cryogenic Class II

FDA Device Classification

Classification Details

Product Code
GXH
Device Class
Class II
Regulation Number
882.4250
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250371atricurecryoICE cryoXT cryoablation probe (cryoXT)April 10, 2025
K243677pacira biosciencesiovera° SystemDecember 26, 2024
K243157atricureAtriCure cryoICE BOX (ACM)October 29, 2024
K233170atricurecryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ CryoablatioOctober 26, 2023
K220656pacira biosciencesiovera SystemMay 20, 2022
K211334pacira pharmaceuticalsIovera SystemSeptember 10, 2021
K200697atricureAtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoaDecember 23, 2020
K182565atricureAtriCure cryoICE cryoSPHERE cryoablation probeNovember 9, 2018
K173763myoscienceiovera systemFebruary 28, 2018
K180138atricureAtriCure cryoICE cryo-ablation probe (CRYO2)February 15, 2018
K161835myoscienceiovera systemMarch 24, 2017
K142866myoscienceMyoscience iovera systemJanuary 21, 2015
K142203atricureAtricure Cryo Module System; cryoICE cryoablation probeNovember 25, 2014
K133453myoscienceIOVERAMarch 24, 2014
K123516myoscienceCRYO-TOUCH IVJanuary 10, 2013
K120415myoscienceCRYO-TOUCH IIIJune 22, 2012
K102021myoscienceCRYO-TOUCH IISeptember 17, 2010
K100447myoscienceMYOSCIENCE CRYO-TOUCHJune 25, 2010
K050272cryomedical instrumentsCRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMSMarch 24, 2005
K031482cryomedical instruemtsCRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) July 10, 2003